Tendon deflection systems such as catheters have been in common use in medical practice for many years. The catheters are used to probe locations inside a body lumen that are otherwise unreachable without surgery. A catheter is inserted into a major vein or artery, or other body lumen that is near the body surface, possibly with the aid of an introducer entering the body lumen and a guide catheter previously inserted.
The catheter is then guided to the area of concern by inserting the catheter further into the body lumen. As medical knowledge increases, catheterizations have become more complicated and exacting. In many situations the ability to control the position and orientation of the catheter tip may largely determine the usefulness of the catheter.
Flexible catheters having deflectable (steerable) tips are also known. Such a catheter generally has a control handle at its proximal end for controlling deflection of the tip in one or more directions. The catheter may also include a puller wire or tendon that extends coaxially (on axis) through an elongated reinforced catheter body and then off axis in a deflectable distal tip portion.
The tendon may be anchored or fixedly attached at or distal to the deflectable tip portion by welding, soldering, brazing, adhesive or other means of attachment to a structure (e.g., electrode or other metal anchor) coupled to the catheter shaft. However, each of these methods of attachment has drawbacks.
For example, welding can weaken and/or melt the wire. In addition, welding deforms the wire, which creates a smaller cross-sectional area in the deformed portion relative to the non-deformed portion. Necessarily, the deformed portion with the smaller cross-sectional area is the weakest part of the wire. Thus, the weakest point of the wire is disadvantageously located at the point of attachment.
Soldering and brazing require the use of flux to facilitate the fusion of the wire to the metal anchor coupled to the catheter shaft. This is problematic since flux is often acidic and, if not thoroughly cleaned from the catheter, will corrode the wire and the bond. In addition, flux tends to discolor the metal (e.g., gives stainless steel a rusted appearance), which makes it difficult to ascertain whether the catheter is sterile before inserting the catheter into a patient's body.
Finally, it is difficult to create an effective bond between metals with an adhesive. Thus, the current techniques of attaching the tendon to the distal portion of the catheter shaft are not acceptable.
Regardless of the method of attachment used, tension on the tendon (made with longitudinal movement of the proximal portion of the tendon) relative to the catheter body or shaft results in the generation of a bending moment in the deflectable tip portion, which causes the catheter tip portion to deflect. The more proximal portions of the catheter body tend not to deflect because the tendon extends coaxially (on axis) within the shaft and, therefore, little bending moment is generated.
The above design operates well in catheters where the work elements of the catheter or catheter system do not materially affect the radial symmetry of the catheter body's flexural modulus, such as in electrophysiology (“EP”) catheters. In an EP catheter, the electrical wires running through the catheter body are very flexible and, if a strain is relieved, have little influence on the catheter body's flexural modulus (e.g., stiffness). However, in catheters or catheter systems with less flexible work elements, the work elements must occupy the axial position within the catheter body and not the tendon.
If the less flexible work element were placed in an off-axis position in the catheter body, the catheter body would have a preferred rotational orientation when rotated within a curved conduit (e.g., within the aorta or at the exit to the introducer sheath). This lack of flexural modulus radial symmetry introduces a phenomenon known as “whipping”, where the ability to control the exact position and orientation of the catheter tip is compromised.
Whipping occurs when the distal end of the catheter does not follow the rotation applied to the catheter on the proximal end in a smooth and continuous manner. Thus, whipping is undesirable in catheter systems where the curved or deflected distal end of the catheter must be rotated to direct the distal end towards a desired structure or the curved end of the catheter must sweep through a desired arc in a controlled manner to perform a desired function.
Two examples of catheters with less flexible work elements are guide catheters and needle catheters. In a guide catheter, or a catheter system including a guide catheter, the less flexible work element is the catheter or device that is delivered and positioned through the inner diameter (“ID”) of the device. In a needle catheter, the less flexible work element is the hollow shaft that provides the injection conduit to the needle and/or the means to advance or retract that needle.
There are several problems with placing the tendon off-axis in the catheter body of such devices. One of the problems is that all portions of the shaft proximal to the anchor point are subjected to the bending moment generated by the tension force on the tendon. One undesirable consequence of the bending moment being expressed in all sections of the catheter shaft proximal to the anchor point during deflection is that these sections become curved to some extent and, thus, have a preferred rotational orientation (lowest energy state) when confined in a curved conduit (e.g., the aorta or at the exit to the introducer sheath), which can cause whipping.
Rotation of the catheter is yet another concern since rotation affects the path length of the tendon. For example, the tendon path length is decreased in rotational positions where the tendon is rotated toward the inside of a conduit curve. Thus, if the tendon's proximal end is held in a fixed position relative to the catheter (typical case) and/or the force applied to the tendon decreases in response to the tendon path length decreasing, the deflection of the tip of the catheter decreases. The decrease in deflection returns energy to the catheter, causing the distal tip to rotate more rapidly than the proximal end.
Conversely, in the rotational positions where the tendon is rotated toward the outside of a conduit curve, the path length is increased. Thus, the tension on the tendon increases, which causes the deflection of the catheter tip to increase as well. This removes energy from the catheter, causing the distal tip to rotate more slowly than the proximal end. This disadvantageously increases the chances of undesired whipping.
Similar problems also occur in tendon systems in which the tension on a tendon (or tendons) is used to perform other functions. One example of such a system is minimally invasive surgical (MIS) devices. During MIS procedures, the surgeon performs surgery through small punctures or incisions using endoscopic devices to guide the manipulation of specialized tools (work devices) which are at or near the distal end of shafts.
The use of a small puncture or incision significantly decreases patient risk, trauma and recovery time when compared to conventional surgery. The specialized tools may include cutting devices, like scissors, biopsy retrieval devices and suturing devices that may be activated by a tendon that is controlled by the surgeon at or near the shaft's proximal end. Another tendon (or tendons) may also be provided for deflection to aid in the positioning of the distal end of the specialized tool by the surgeon.